The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.

This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.

The industry consensus on decontamination at the present time is to eliminate detectible levels of microorganisms on non-product contact surfaces within the isolator environment. This can be accomplished by treating a pre-cleaned and properly designed isolator with a sporicidal agent in a quantifiable and reproducible manner with contact points kept to a minimum during the decontamination cycle.

This article presents the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.